Cryoneurolysis for Facet Mediated Chronic Low Back Pain

Inclusion Criteria: 1. Male or female volunteers, at least 18 years of age at screening 2. Primary complaint of axial low-back pain suggestive of unilateral or bilateral facet joint involvement (i.e., facet mediated CLBP) 3. Low back pain is chronic (i.e., \> 3 months' duration) 4. Low back pain score of ≥ 4 (i.e., moderate pain) on the 0 to 10 NRS or functional impairment at screening 5. Successful trial of two diagnostic medial branch blocks consisting of two positive blocks with local anesthetic only (i.e., no steroids) that results in at least 50% relief of primary (index) pain for the duration of the local anesthetic used or history of a positive response to prior radiofrequency treatment (i.e., ≥ 6 months prior to enrollment) 6. Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, spinal injections, NSAIDs or other appropriate analgesics), 7. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments Exclusion Criteria: 1. Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine 2. Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following: 1. Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction) 2. Infection 3. Tumor 4. Traumatic fracture 5. Systemic inflammatory spondyloarthropathy 6. Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit) 7. Neurogenic claudication 3. Prior lumbar spinal fusion surgery 4. Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study including lumbar radiculopathy and neuropathic pain disorder 5. Currently pregnant, nursing, or planning to become pregnant during the study 6. Known contraindication to study devices, including any of the following: 1. Cryoglobulinemia 2. Paroxysmal cold hemoglobinuria 3. Cold urticaria 4. Raynaud's disease 5. Open and/or infected wounds at or near the treatment site 6. Coagulopathy 7. 3.5-inch needle cannot be used in the low back region because of habitus 8. Severe chronic pain disorder that in the opinion of the investigator may impact postsurgical outcomes 9. Presence of any of the following: 1. Spinal neurostimulator 2. Intrathecal analgesic drug pump 10. Current manifestation of poorly controlled mental illness that in the opinion of the i…